Stadalax 5 mg 20 film-coated tablets

STADALAX

5 mg, coated tablets

Bisacodylum

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist for further information or advice.

- If you get any side effects, talk to your doctor or pharmacist. Do the same for any side effects not listed in this leaflet.

- If you feel unwell within 2 days or if you feel uncomfortable, you should consult your doctor.

  

 1. What STADALAX is and what it is used for

STADALAX is a laxative that belongs to the group of so-called triarylmethane drugs.

STADALAX is in use

For short-term treatment of constipation and in diseases where it is necessary that the stool be soft and emptying easy.

 

2. What you need to know before you take STADALAX

DO NOT take STADALAX

- if you are allergic to bisacodyl or any of the other ingredients.

- if you suffer from the following problems, such as abdominal pain, nausea, vomiting, fever. These problems may be signs of a serious illness (intestinal obstruction with acceleration of intestinal peristalsis (bowel movements), ileus, acute abdominal inflammation, acute abdominal pain which must be treated chirugically, eg appendicitis). If you experience the above symptoms, seek medical attention immediately.

- if you have a condition associated with water and electrolyte imbalance (eg severe dehydration / drainage)

- do          not administer to children under 2 years of age

 

Warnings and precautions

Ask your doctor or pharmacist for advice before taking STADALAX

In case of constipation, the laxatives should only be used for a short time.

If you suffer from chronic constipation, consult your doctor before taking this medicine.

Increased fluid loss can lead to dehydration. This may have harmful health consequences in certain cases (eg in patients with renal impairment or in the elderly). In these cases, STADALAX should be discontinued and should only be restarted under the supervision of a doctor. 

Some patients developed stool blood while taking this medicine. Usually, it appeared only in small quantities and these difficulties have self-relieved. However, always tell your doctor to rule out other conditions.

 

Other medicines and STADALAX

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Anti-gastric acid-neutralizing agents (antacids)

Do not take antacids with STADALAX to prevent the active substance of STADALAX from being released prematurely.

If you need an antacid, do not take it less than half an hour after taking STADALAX.

Diuretic drugs, adrenal cortex hormones

The active substance in this medicine, bisacodyl, may increase potassium loss (excretion) caused by diuretics or adrenal cortex hormones)

Medicines to strengthen heart activity

As a result of potassium loss, sensitivity to some heart-enhancing drugs (cardiac glycosides) may increase

Taking STADALAX with food and drink

Do not take STADALAX with milk.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

No harmful or adverse effects have been reported with bisacodyl during pregnancy. However, studies evaluating its use during pregnancy have not been performed. Therefore, STADALAX should only be used during pregnancy on the advice of a doctor.

The active substance in STADALAX does not pass into milk, so it can be taken while breast-feeding.

 

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

However, please keep in mind that side effects such as dizziness or abdominal cramps may occur that could impair your ability to drive or use machines.

STADALAX contains glucose, lactose and sucrose .

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

3. How to take STADALAX

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist

The recommended dose of STADALAX is:

Use in children:

Children 10 years of age and younger with chronic constipation should only be treated under the supervision of a doctor.

Bisacodyl should not be given to children under 2 years of age.

 

Short-term treatment of constipation:

Adults, adolescents and children over 10 years of age:

1-2 tablets (5-10 mg) / day before bedtime are given for immediate effect.

Children 2-10 years:

For immediate effect, a 1-pack tablet (5mg) / day at bedtime is given.

 

Method of administration

The tablets should be taken in the morning or in the evening on an empty stomach and swallowed with plenty of liquid.

Do not chew the tablets.

If you take STADALAX in the evening, you will experience a bowel urge approximately 10 hours afterwards.

If you take STADALAX in the morning on an empty stomach, you will experience urge to stool approximately 6 hours afterwards.

 

Duration of treatment

STADALAX can only be used for a short period (up to one week) without consulting your doctor. If you suffer from chronic (prolonged) constipation, consult your doctor.

Please consult your doctor if you think the effect of STADALAX is too strong or too weak.

 

If you take more STADALAX tablets than you should

Overdose may lead to diarrhea and abdominal cramps. At the same time, there are large losses of liquids, potassium and other electrolytes (minerals). If you experience these problems, consult your doctor.

The way in which overdose is treated depends on the prevalence of symptoms. If necessary, losses of liquids and salts (especially potassium) must be compensated

 

Notice

It is generally known that prolonged excessive use of laxatives (eg STADALAX) may result in chronic diarrhea, abdominal pain, decreased potassium levels in the blood, increased secretion of aldosterone (adrenal cortex hormone) or kidney stones. There have also been reports of kidney tissue damage, increased blood alkaline concentrations (metabolic alkalosis) and muscle weakness (due to low potassium levels in the blood) due to prolonged excessive use of laxatives.

 

If you forget to take a regular dose of STADALAX

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

 

Package contents and other information

What STADALAX contains

The active substance is jebisacodylum 5 mg per 1 film-coated tablet

The other ingredients of STADALAX are:

microcrystalline cellulose, celacephate, liquid glucose syrup, mixture of mono-, di, triglycerides, potato starch, lactose monohydrate, magnesium stearate, corn starch, dextrin, virgin castor oil, sucrose, colloidal anhydrous silica, talc, montanglycol wax, titanium dioxide ,

 

What STADALAX looks like and contents of the pack

STADALAX are white, smooth, round, biconvex, coated tablets in a blister pack.

Pack size:

20 coated tablets

 

MEDICINAL PRODUCT, READ CAREFULLY PACKAGE LEAFLET.